API International Training Programme

The International API Training Programme (API ITP) consists of 3 segments related to the PIC/S GMP Guide, Part II (ICH Q7). The segments include (i) General Training on ICH Q7, which is open to Regulators and industry; (ii) Advanced Training which is open to Regulators only and (iii) Q&A for Regulators and industry. The API ITP is led by the PIC/S Expert Circle on API.

PIC/S - PDA ICH Q7 Training, Ahmedabad (India), 2015

Lecture’s attitude for questions was very nice. Also, I feel they are real experts!

Key Features

The International API Training Programme (API ITP) was developed by the PIC/S Expert Circle on API. This training programme was established at the request of a number of National Medicines Regulatory Authorities. The objective of the programme is to raise GMP awareness amongst Inspectorates, Inspectors and industry in relation to API manufacture as well as their supply chain and the harmonisation of the application of ICH Q7 (PIC/S GMP Guide, Part II) to the inspection of API manufacturers.

The API ITP is also intended to provide an update as well as training on current issues and future challenges for API inspections such as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) documents related to quality topics (Q8, Q9, Q10, Q11) and supply chain (falsification/ adulteration) issues.

The objectives of the three segments of the API ITP related to PIC/S GMP Guide, Part II (ICH Q7) are:

API ITP General Training

API ITP General Training is elaborated by Regulators and industry for Regulators and industry. It aims at delivering ICH Q7 guidance training at a global level in several locations around the world, in particular in key regions of API manufacturing. Given that there were a number of Professional Associations which already had training material on this topic, collaboration was sought with one or more of these associations to review, revise and deliver training. The Parenteral Drug Association (PDA) was identified.

The General Training material covers all ICH Q7 sections with specific additions on Q7 technical related-technical topics such as data integrity, supplier qualification, starter material, EU Falsified Medicines Directive (FMD). Inspection techniques are only discussed as part of the Advanced Training for Inspectors only (Expert Circle meetings).

API ITP General Trainings have taken place in:

2016

Puerto Rico | San Juan

2015

China | Beijing

2015

India | Hyderabad & Ahmedabad

2015

Brazil | Brasilia

2015

Korea (Republic of) | Seoul

2014

Belgium | Brussels

2014

South Africa | Pretoria

2013

USA | Washington DC

2012

Portugal | Lisbon

2012

China | Beijing

API ITP Advanced Training

API ITP Advanced Training is elaborated by Regulators and for some parts by industry, for Regulators only. It aims at delivering advanced training during API Expert Circle meetings in order to meet the challenges arising through regulation of the global API production and supply chain. Advanced Training has taken place within the frame of the following Expert Circle on API Meetings: